Orionex Regulatory Solutions

Orionex Regulatory Solutions — FDA Registration & U.S. Agent Services

Orionex Regulatory Solutions, a division of Orionex Trading LLC, is a U.S.-based FDA regulatory consulting firm headquartered in Casper, Wyoming. With over 15 years of experience, we specialize in helping manufacturers and exporters worldwide achieve full compliance with U.S. Food and Drug Administration requirements. Our services span FDA facility registration, U.S. Agent designation, product listing, label review, and regulatory consulting across all major product categories — including food and dietary supplements, medical devices, pharmaceutical drugs, and cosmetics (MoCRA).

As a licensed and designated U.S. Agent under FDA regulations, Orionex serves as the official point of contact between foreign facilities and the FDA. We manage all regulatory correspondence, renewal deadlines, and compliance updates on behalf of our clients — ensuring uninterrupted market access to the United States. Our team brings deep expertise across CDER, CDRH, CFSAN, and beyond, with a 98% first-round FDA acceptance rate that reflects our commitment to precision and thoroughness in every submission.

Trusted by clients in over 50 countries, Orionex is built on a foundation of transparency, integrity, and speed. We offer upfront, all-inclusive pricing with no hidden fees, and our regulatory team begins work within one business day of order confirmation. Whether you are registering with the FDA for the first time or managing ongoing compliance obligations, Orionex delivers expert guidance, fast turnaround, and a dedicated account manager — every step of the way.